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A Study of Lanabecestat (LY3314814) in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02663128
Recruitment Status : Completed
First Posted : January 26, 2016
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to measure how much of a new tablet formulation of lanabecestat gets into the blood stream and how long it takes the body to get rid of it, compared to the current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the body absorbs the new tablet formulation will also be evaluated. In addition any side effects of the study drug using both the new and current tablet formulations will be evaluated. The study will last about 22 days, with screening required within 30 days prior to the start of the study.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lanabecestat Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Bioequivalence and Food Effect Study in Healthy Subjects Administered 2 Different Tablet Formulations of LY3314814
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Lanabecestat Reference Fasted
Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: Lanabecestat Test Fasted
Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: Lanabecestat Test Non Fasted
Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293




Primary Outcome Measures :
  1. Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293) [ Time Frame: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose ]
  2. PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293) [ Time Frame: Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose ]
  3. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293) [ Time Frame: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Male participants: Will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product

- Female participants: Women not of childbearing potential due to surgical sterilization or confirmed by medical history or menopause

- Are able to eat a high-fat, high-calorie meal within the defined time limit and abide by the food restrictions throughout the study

Exclusion Criteria:

  • Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
  • Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • History of previous or ongoing psychiatric disease/condition
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study, or have a history of significant dysrhythmias or atrioventricular (AV) block (including first degree AV block). Participants with history of persistent PR interval greater than (>)200 milliseconds (msec) will be excluded
  • Have prolonged Fridericia-corrected QT interval (QTcF) of >470 msec
  • Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator
  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Are unwilling to comply with the dietary requirements/restrictions during the study
  • Evidence of active renal disease (e.g, diabetic renal disease, polycystic kidney disease) or calculated creatinine clearance <50 milliliters per minute (mL/min)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663128


Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02663128     History of Changes
Other Study ID Numbers: 16001
I8D-MC-AZEH ( Other Identifier: Eli Lilly and Company )
First Posted: January 26, 2016    Key Record Dates
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019
Last Verified: December 2018